Oncology drug pricing: potential Medicare savings on cancer-directed and supportive care medications through the Mark Cuban cost plus drug model.

Prescription drug costs within oncology remain a challenge for many patients with cancer. The Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022, aiming to provide transparently priced medications at reduced costs. In this study, we sought to describe the potential impact of MCCPDC on Medicare Part-D oncology spending related to cancer-directed (n = 7) and supportive care (n = 26) drugs. We extracted data for drug-specific Part-D claims and spending for 2021. Using 90-count purchases from MCCPDC, we found potential Part-D savings of $857.8 million (91% savings) across the 7 cancer-directed drugs and $28.7 million (67% savings) across 21/26 (5/26 did not demonstrate savings) supportive care drugs. Collectively, our findings support that alternative purchasing models like MCCPDC may promote substantial health care savings.

Out-of-pocket prescription drug costs for adults with cardiovascular risk factors under Amazon's direct-to-consumer pharmacy service.

BACKGROUND: US adults often overpay for generic prescription medications, which can lead to medication nonadherence that negatively impacts cardiovascular outcomes. As a result, new direct-to-consumer online medication services are growing in popularity nationwide. Amazon recently launched a $5/month direct-to-consumer medication subscription service (Amazon RxPass), but it is unclear how many US adults could save on out-of-pocket drug costs by using this new service. OBJECTIVES: To estimate out-of-pocket savings on generic prescription medications achievable through Amazon's new direct-to-consumer subscription medication service for adults with cardiovascular risk factors and/or conditions. METHODS: Cross-sectional study of adults 18-64 years in the 2019 Medical Expenditure Panel Survey. RESULTS: Of the 25,280,517 (SE ± 934,809) adults aged 18-64 years with cardiovascular risk factors or conditions who were prescribed at least 1 medication available in the Amazon RxPass formulary, only 6.4% (1,624,587 [SE ± 68,571]) would achieve savings. Among those achieving savings, the estimated average out-of-pocket savings would be $140 (SE ± $15.8) per person per year, amounting to a total savings of $228,093,570 (SE ± $26,117,241). In multivariable regression models, lack of insurance coverage (adjusted odds ratio [OR] 3.5, 95%CI 1.9-6.5) and being prescribed a greater number of RxPass-eligible medications (2-3 medications versus 1 medication: OR 5.6, 95%CI 3.0-10.3; 4+ medications: OR 21.8, 95%CI 10.7-44.3) were each associated with a higher likelihood of achieving out-of-pocket savings from RxPass. CONCLUSIONS: Changes to the pricing structure of Amazon's direct-to-consumer medication service are needed to expand out-of-pocket savings on generic medications to a larger segment of the working-age adults with cardiovascular risk factors and/or diseases.

Availability and Cost of Expensive and Common Generic Prescription Drugs: A Cross-sectional Analysis of Direct-to-Consumer Pharmacies.

BACKGROUND: Direct-to-consumer (DTC) pharmacies sell generic prescription drugs, often at lower prices than traditional retail pharmacies; however, not all drugs are available, and prices vary. OBJECTIVE: To determine the availability and cost of generic drugs at DTC pharmacies. DESIGN: Cross-sectional study. SETTING: Five national DTC pharmacies in April and May 2023. PARTICIPANTS: Each qualifying form of 100 generic drugs with the highest cost-per-patient (expensive) and the 50 generic drugs with the highest number of patients (common) in Medicare Part D in 2020 MAIN MEASURES: Availability of these drugs and the lowest DTC pharmacy price for a standardized drug strength and supply (e.g., 30 pills), compared to GoodRx retail pharmacy prices. KEY RESULTS: Of the 118 expensive generic dosage forms, 94 (80%) were available at 1 or more DTC pharmacies; out of 52 common generic dosage forms, 51 (98%) were available (p < 0.001). Of the 88 expensive generics available in comparable quantities and strengths across pharmacies, 42 (47%) had the lowest cost at Amazon, 23 (26%) at Mark Cuban Cost Plus Drug Company, 13 (14%) at Health Warehouse, and 12 (13%) at Costco; for 51 common generic formulations, 16 (31%) had the lowest cost at Costco, 14 (27%) at Amazon, 10 (20%) at Walmart, 6 (12%) at Health Warehouse, and 5 (10%) at Mark Cuban Cost Plus Drug Company. For the 77 expensive generics with available GoodRx retail pharmacy prices, the median cost savings at DTC pharmacies were $231 (95% CI, $129-$792) or 76% (IQR, 53-91%); for 51 common generics, savings were $19 (95% CI, $10-$34) or 75% (IQR, 67-83%). CONCLUSIONS: Many of the most expensive generic drugs are unavailable at direct-to-consumer pharmacies. Meanwhile, less expensive, commonly used generics are widely available, but drug prices vary by pharmacy and savings are modest, requiring patients to shop around for the lowest cost.

Auditing the prescription drug consumer price index in a changing marketplace.

Changes in the dynamics of prescription drug markets have raised issues regarding whether the United States Bureau of Labor Statistics' (BLS') Prescription Drug Consumer Price Index (CPI-Rx) has adequately kept up with the evolving marketplace. The CPI-Rx limits its sampling frame to retail outpatient outlets and excludes prescription pharmaceuticals dispensed in non-retail settings such as hospitals, physician/clinic outpatient facilities, and nursing homes. Thus, the CPI-Rx overlooks the increasingly important specialty pharmaceuticals dispensed in non-retail settings, whose transactions are instead captured in the overall hospital and professional services component of the medical care CPI. Specialty drugs now account for about 55% of all U.S. drug spending, double the share of a decade earlier. To the extent specialty drug price growth differs from that of traditional pharmaceuticals, the CPI-Rx could provide an inaccurate measure of overall drug price inflation. We calculate a chained Laspeyres CPI using data from the Merative™ MarketScan® Databases for the years 2010-2019 and IQVIA-designated specialty drugs and offer evidence showing that by not sampling specialty drugs in non-retail settings, the CPI-Rx has understated overall U.S. prescription drug inflation by just under 75 basis points annually. We discuss implications for health care policy and suggest the BLS examine the feasibility of publishing an overall pharmaceutical price index incorporating both traditional and specialty pharmaceuticals dispensed in retail and non-retail settings.

The Medicines Intelligence Data Platform: A Population-Based Data Resource From New South Wales, Australia.

BACKGROUND: The Medicines Intelligence (MedIntel) Data Platform is an anonymised linked data resource designed to generate real-world evidence on prescribed medicine use, effectiveness, safety, costs and cost-effectiveness in Australia. RESULTS: The platform comprises Medicare-eligible people who are ≥18 years and residing in New South Wales (NSW), Australia, any time during 2005-2020, with linked administrative data on dispensed prescription medicines (Pharmaceutical Benefits Scheme), health service use (Medicare Benefits Schedule), emergency department visits (NSW Emergency Department Data Collection), hospitalisations (NSW Admitted Patient Data Collection) plus death (National Death Index) and cancer registrations (NSW Cancer Registry). Data are currently available to 2022, with approval to update the cohort and data collections annually. The platform includes 7.4 million unique people across all years, covering 36.9% of the Australian adult population; the overall population increased from 4.8 M in 2005 to 6.0 M in 2020. As of 1 January 2019 (the last pre-pandemic year), the cohort had a mean age of 48.7 years (51.1% female), with most people (4.4 M, 74.7%) residing in a major city. In 2019, 4.4 M people (73.3%) were dispensed a medicine, 1.2 M (20.5%) were hospitalised, 5.3 M (89.4%) had a GP or specialist appointment, and 54 003 people died. Anti-infectives were the most prevalent medicines dispensed to the cohort in 2019 (43.1%), followed by nervous system (32.2%) and cardiovascular system medicines (30.2%). CONCLUSION: The MedIntel Data Platform creates opportunities for national and international research collaborations and enables us to address contemporary clinically- and policy-relevant research questions about quality use of medicines and health outcomes in Australia and globally.

The Cost of Medications at a Student-Run Free Clinic in New Haven, Connecticut, 2021-2023.

Introduction: Haven is a student-run free clinic in New Haven, Connecticut, that serves more than 500 patients annually. Haven's pharmacy department helps patients obtain medications by providing discount coupons or medications from the clinic's in-house pharmacy, directly paying for medications at local pharmacies, and delivering medications to patients' homes. This study aimed to identify prescriptions that have the highest cost among Haven patients. Methods: Our sample consisted of all Haven patients who attended the clinic from March 2021 through March 2023. Patients were eligible to be seen at Haven if they were aged 18 to 65 years, lacked health insurance, and lived in New Haven. We determined the lowest cost of each medication prescribed to Haven patients by comparing prices among local pharmacies after applying a GoodRx discount. We defined expensive medication as more than $20 per prescription. We excluded medical supplies. Results: Of the 594 Haven patients in our sample, 64% (n = 378) required financial assistance and 22% (n = 129) were prescribed at least 1 expensive medication. Among 129 patients prescribed an expensive medication, the mean (SD) age was 45.0 (12.3) years; 65% were women, and 87% were Hispanic or Latino. Median (IQR) household annual income was $14,400 [$0-$24,000]. We identified 246 expensive medications; the median (IQR) price per prescription was $31.43 ($24.00-$52.02). The most frequently prescribed expensive medications were fluticasone propionate/salmeterol (accounting for 6% of all expensive medications), medroxyprogesterone acetate (6%), albuterol sulfate (5%), and rosuvastatin (5%). Conclusion: The average Haven patient has an income well below the federal poverty level, and many have chronic cardiovascular and respiratory conditions that require expensive medications. Future research should work toward making medications universally affordable.

Federal Trade Commission Actions on Prescription Drugs, 2000-2022.

Importance: The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. This study characterized the FTC's policy on the pharmaceutical market in recent decades, identifying the types of actions it has favored, barriers it has faced, and authorities that remain untested. Objective: To review FTC legal actions in the pharmaceutical market from 2000-2022. Evidence Review: Legal actions were determined through manual review of search results from the FTC's online Legal Library as well as a 2023 FTC report on pharmaceutical actions. The alleged misconduct, type of legal action taken, timing, and outcome were collected from press releases, complaints, orders, and other legal documents. Findings: From 2000-2022, the FTC challenged 62 mergers, brought 22 enforcement actions against allegedly unlawful business practices, and made 1 rule related to pharmaceuticals. Alleged misconduct in enforcement actions involved anticompetitive settlements in patent litigation (n = 11), unilateral actions by brand manufacturers to delay generic competition (n = 6), noncompete agreements (n = 4), and monopolization (n = 3), with 10 outcomes involving monetary payment, totaling $1.6 billion. Of the 62 mergers the FTC challenged, 61 were allowed to continue, 58 after divesting certain drugs to third-party competitors. The FTC's reliance on drug divestitures decreased from 18 drugs per year from 2000-2017 to 4.3 per year from 2017-2023. Conclusions and Relevance: The FTC brought about 1 enforcement action and 3 merger actions per year against pharmaceutical manufacturers from 2000-2022, pursuing a small fraction of the estimated misconduct and consolidation in the pharmaceutical marketplace. Although the FTC faces substantial legal and practical limitations, important tools remain untested, including a rule defining "unfair methods of competition," that may allow it to more effectively prevent repetitive patterns of anticompetitive behavior.

Barriers to Ensuring Access to Affordable Prescription Drugs.

High and rising prescription drug costs have become a preoccupying policy problem in the United States. Notwithstanding broad, bipartisan interest in finding effective policy solutions, several aspects of the drug affordability problem make it an uncommonly difficult one to solve. This article reviews the moral, market, and political factors contributing to the difficulty. Among the moral problems is lack of agreement about how to weigh the fundamental tradeoff involved in regulating drug prices-affordability versus incentives for innovation-and about what constitutes a fair price. Market-related factors include the lack of price transparency and a myriad of perverse incentives in the system through which prescription drugs are supplied to patients. Finally, current policy choices are constrained by past political compromises, and an atmosphere of scandal focusing on egregious instances of price gouging has made rational deliberation about fixes to deeper problems in the system difficult.

Medical Expenditures Associated with Attention-Deficit/Hyperactivity Disorder Among Adults in the United States by Age, 2015-2019.

BACKGROUND: Attention-deficit hyperactivity disorder is a common disorder that affects both children and adults. However, for adults, little is known about ADHD-attributable medical expenditures. OBJECTIVE: To estimate the medical expenditures associated with ADHD, stratified by age, in the US adult population. DESIGN: Using a two-part model, we analyzed data from Medical Expenditure Panel Survey for 2015 to 2019. The first part of the model predicts the probability that individuals incurred any medical costs during the calendar year using a logit model. The second part of the model estimates the medical expenditures for individuals who incurred any medical expenses in the calendar year using a generalized linear model. Covariates included age, sex, race/ethnicity, geographic region, Charlson comorbidity index, insurance, asthma, anxiety, and mood disorders. PARTICIPANTS: Adults (18 +) who participated in the Medical Expenditure Panel Survey from 2015 to 2019 (N = 83,776). MAIN MEASURES: Overall and service specific direct ADHD-attributable medical expenditures. KEY RESULTS: A total of 1206 participants (1.44%) were classified as having ADHD. The estimated incremental costs of ADHD in adults were $2591.06 per person, amounting to $8.29 billion nationally. Significant adjusted incremental costs were prescription medication ($1347.06; 95% CI: $990.69-$1625.93), which accounted for the largest portion of total costs, and office-based visits ($724.86; 95% CI: $177.75-$1528.62). The adjusted incremental costs for outpatient visits, inpatient visits, emergency room visits, and home health visits were not significantly different. Among older adults (31 +), the incremental cost of ADHD was $2623.48, while in young adults (18-30), the incremental cost was $1856.66. CONCLUSIONS: The average medical expenditures for adults with ADHD in the US were substantially higher than those without ADHD and the incremental costs were higher in older adults (31 +) than younger adults (18-30). Future research is needed to understand the increasing trend in ADHD attributable cost.

Added Therapeutic Benefit of Top-Selling Brand-name Drugs in Medicare.

Importance: The Inflation Reduction Act of 2022 authorizes Medicare to negotiate prices of top-selling drugs based on several factors, including therapeutic benefit compared with existing treatment options. Objective: To determine the added therapeutic benefit of the 50 top-selling brand-name drugs in Medicare in 2020, as assessed by health technology assessment (HTA) organizations in Canada, France, and Germany. Design, Setting, and Participants: In this cross-sectional study, publicly available therapeutic benefit ratings, US Food and Drug Administration documents, and the Medicare Part B and Part D prescription drug spending dashboards were used to determine the 50 top-selling single-source drugs used in Medicare in 2020 and to assess their added therapeutic benefit ratings through 2021. Main Outcomes and Measures: Ratings from HTA bodies in Canada, France, and Germany were categorized as high (moderate or greater) or low (minor or no) added benefit. Each drug was rated based on its most favorable rating across countries, indications, subpopulations, and dosage forms. We compared the use and prerebate and postrebate (ie, net) Medicare spending between drugs with high vs low added benefit. Results: Forty-nine drugs (98%) received an HTA rating by at least 1 country; 22 of 36 drugs (61%) received a low added benefit rating in Canada, 34 of 47 in France (72%), and 17 of 29 in Germany (59%). Across countries, 27 drugs (55%) had a low added therapeutic rating, accounting for $19.3 billion in annual estimated net spending, or 35% of Medicare net spending on the 50 top-selling single-source drugs and 11% of total Medicare net prescription drug spending in 2020. Compared with those with high added benefit, drugs with a low added therapeutic rating were used by more Medicare beneficiaries (median 387 149 vs 44 869) and had lower net spending per beneficiary (median $992 vs $32 287). Conclusions and Relevance: Many top-selling Medicare drugs received low added benefit ratings by the national HTA organizations of Canada, France, and Germany. When negotiating prices for these drugs, Medicare should ensure they are not priced higher than reasonable therapeutic alternatives.

Differential Effects by Mental Health Status of Filling the Medicare Part D Coverage Gap.

OBJECTIVE: The objective of this study was to study how changes in insurance benefit design affect medication use of older adults with mental disorders. DATA SOURCES: US Medicare claims data from 2007 to 2018. STUDY DESIGN: Exploiting the gradual elimination of the Medicare prescription drug coverage gap beginning in 2011, we examine the effects on medication use and out-of-pocket spending by drug type with a difference-in-differences approach. We identify subpopulations by mental disorder and compare the estimates across mental health groups and to the general Medicare population. PRINCIPAL FINDINGS: Closing the gap substantially reduced individuals' out-of-pocket spending, and the reduction was larger for those with more severe mental disorders. The policy led to a statistically significant increase in branded drugs used for the Medicare population (0.91; P<0.01; 12.12% increase), beneficiaries with severe mental disorders (2.71; P<0.01; 11.13% increase), and common mental disorders (2.63; P<0.01; 11.62% increase), whereas such effect for beneficiaries with Alzheimer disease and dementia (AD) is substantially smaller (0.44; P<0.01; 1.83% increase). In contrast, the policy decreased generic drugs used by about 3%-5% for all groups. Overall, beneficiaries without mental health illness have a statistically significant increase in total medication use (2.05%) following the coverage gap closure, while all 3 mental health groups have either no statistically significant changes or a small reduction in total mediation use (AD, -1.26%). CONCLUSIONS: Patients' responses to price changes vary across mental disorders and by drug type. The impact on branded drug utilization among those with AD is particularly small. Our findings suggest that lowering medication costs has differential impacts across diseases and may not be sufficient to improve adherence for all conditions, in particular those with severe mental health disorders such as AD.

Incentivizing Prescription Drug Switching to Reduce Patient and Health Plan Spending: A Microsimulation Model.

OBJECTIVES: Most spending for prescription drugs is on branded drugs that do not have direct generic equivalents but many of these drugs do have therapeutic alternatives within class. We estimate the potential savings from providing patients a financial incentive to switch from a higher cost drug to a lower cost, therapeutic alternative drug. METHODS: We used individual state-transition microsimulations to model medication use and spending with and without financial incentives over a 12-month time horizon with a healthcare sector perspective. Costs and utilization inputs were from individuals on branded insulins or multiple sclerosis drugs enrolled in a regional mixed-model health maintenance organization. Base-case model used a one-time financial incentive of $83 and $250 offered to patients on higher cost insulin and multiple sclerosis treatments, respectively, to switch to lower cost drugs within class. RESULTS: Savings per individual offered an incentive in the insulin and multiple sclerosis classes were, respectively, $84 (95% CI $46-$122) and $2,127 (95% CI $267-$3,987). Varying the incentive size and switch probability resulted in maximum savings of $712 at elasticity of 0.2 and incentive size $250 for the insulin drug class. For the multiple sclerosis drug class, maximum savings of $5945 was at elasticity of 0.2 and incentive size of $1000. Short time horizon makes our savings estimates conservative. CONCLUSIONS: If programs such as financial incentives could encourage even a small proportion of patients to switch among drugs within therapeutic class, then substantial savings could be generated.

Impact of the National Centralized Drug Procurement Policy (4 + 7 policy) on the drug expenditures of patients treated in outpatient and emergency departments in a large tertiary level-A hospital in China: A single centre, interrupted time series.

WHAT IS KNOWN AND OBJECTIVE: Like many countries in the world, China is also facing growing drug expenditures year by year. In particular, the rising cost of prescription drugs has been one of the critical factors leading to the serious burden on health insurance programs. The high cost of prescription drugs not only threatens the health budget but also limits the nation's investment in other public sectors. China implemented the National Centralized Drug Procurement (NCDP) policy, also known as the "4 + 7" policy, in tertiary hospitals in various provinces and cities across the country on 18 December 2019, aiming to lessen personal and national health insurance burdens by reducing drug procurement prices. The aim of this study is to explore the impact of the implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments and on national health insurance expenditures. METHODS: This study adopts interrupted time series (ITS) to evaluate the impact of China's implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments in a tertiary hospital. The NCDP policy was officially implemented on 18 December 2019. A segmented regression model is utilized to analyse the average monthly drug expenditures of patients treated in outpatient and emergency departments from January 2018 to June 2021, including the average monthly per-visit drug expenditures of all patients and the average monthly per-visit drug expenditures of patients who paid for drugs with health insurance and those who did not use health insurance. RESULTS: After the implementation of the NCDP policy, the overall average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments were immediately reduced by 233.954 CNY (p < 0.01). Compared with the continued downward trend for drug expenditures before the implementation of the NCDP policy, the long-term trend after policy implementation was not obvious (p = 0.051973>0.05). Similarly, the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who use health insurance to procure drugs also immediately decreased by 505.287 CNY (p < 0.01), but the long-term trends before (p = 0.469>0.05) and after policy implementation (p = 0.51>0.05) did not exhibit obvious change. For the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who did not use health insurance, the implementation of the NCDP policy did not produce an immediate reduction in drug expenditures (p = 0.3603>0.05). Although the average monthly per-visit drug expenditures decreased by 9.078 CNY (p < 0.01) before policy implementation, this trend ended after the policy was implemented (p = 0.0735>0.05), and no other changes were triggered. WHAT IS NEW AND CONCLUSION: This study reviews the data for a period of time before and after the implementation of the NCDP policy. The policy is shown to significantly decrease the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments.

Prescription Drug Spending in Fee-for-Service Medicare, 2008-2019.

Importance: Prescription drug spending is a topic of increased interest to the public and policymakers. However, prior assessments have been limited by focusing on retail spending (Part D-covered drugs), omitting clinician-administered (Part B-covered) drug spending, or focusing on all fee-for-service Medicare beneficiaries, regardless of their enrollment into prescription drug coverage. Objective: To estimate the proportion of health care spending contributed by prescription drugs and to assess spending for retail and clinician-administered prescriptions. Design, Setting, and Participants: Descriptive, serial, cross-sectional analysis of a 20% random sample of fee-for-service Medicare beneficiaries in the United States from 2008 to 2019 who were continuously enrolled in Parts A (hospital), B (medical), and D (prescription drug) benefits, and not in Medicare Advantage. Exposure: Calendar year. Main Outcomes and Measures: Net spending on retail (Part D-covered) and clinician-administered (Part B-covered) prescription drugs; prescription drug spending (spending on Part B-covered and Part D-covered drugs) as a percentage of total per-capita health care spending. Measures were adjusted for inflation and for postsale rebates (for Part D-covered drugs). Results: There were 3 201 284 beneficiaries enrolled in Parts A, B, and D in 2008 and 4 502 718 in 2019. In 2019, beneficiaries had a mean (SD) age of 71.7 (12.0) years, documented sex was female for 57.7%, and 69.5% had no low-income subsidies. Total per-capita spending was $16 345 in 2008 and $20 117 in 2019. Comparing 2008 with 2019, per-capita Part A spending was $7106 (95% CI, $7084-$7128) vs $7120 (95% CI, $7098-$7141), Part B drug spending was $720 (95% CI, $713-$728) vs $1641 (95% CI, $1629-$1653), Part B nondrug spending was $5113 (95% CI, $5105-$5122) vs $6702 (95% CI, $6692-$6712), and Part D net spending was $3122 (95% CI, $3117-$3127) vs $3477 (95% CI, $3466-$3489). The proportion of total annual spending attributed to prescription drugs increased from 24.0% in 2008 to 27.2% in 2019, net of estimated rebates and discounts. Conclusions and Relevance: In 2019, spending on prescription drugs represented approximately 27% of total spending among fee-for-service Medicare beneficiaries enrolled in Part D, even after accounting for postsale rebates.

Trajectory of excess healthcare consultations, medication use, and work disability in newly diagnosed knee osteoarthritis: a matched longitudinal register-based study.

PURPOSE: To estimate the excess healthcare use and work disability attributable to knee osteoarthritis (OA) in the first 5 years following diagnosis. METHODS: Among individual aged 40-80 years who resided in Skåne on 31st December 2008, we identified those with a main diagnosis of knee OA during 2009-2014 and no previous diagnosis of any OA from 1998 (n = 16,888). We created a comparison cohort matched (1:1) by sex, age, and municipality from individuals with no OA diagnosis (at any site) during 1998-2016. We compared healthcare use and net disability days for 60 months following diagnosis between the two groups. We applied a survival-adjusted regression technique controlling for sociodemographic characteristics as well as pre-diagnosis outcome and comorbidity. RESULTS: The estimated 5-year incremental effects of knee OA per-patient were 16.8 (95% CI: 15.8, 17.7) healthcare consultations, 0.7 (0.4, 1.1) inpatient days, 420 (372, 490) defined daily dose of prescribed medications, and 21.8 (15.2, 30.0) net disability days. Primary care consultations constituted about 73% of the excess healthcare consultations. Most of these incremental effects occurred in the first year after diagnosis. Better survival in the knee OA group accounted for 0.7 (95% CI: 0.5, 0.8) and 1.4 (0.7, 2.6) of the excess healthcare consultations and net disability days, respectively. Both estimated total and incremental resources use were generally greater for women than men with knee OA. CONCLUSION: Knee OA was associated with considerable excess healthcare use and work disability independent of pre-diagnosis resources use, comorbidity, and sociodemographic characteristics.

Trends in Health Care Utilization and Expenditures in the United States Across 5 Decades: 1977-2017.

BACKGROUND: Health care expenditures in the United States are high and rising, with significant increases over the decades. The delivery, organization, and financing of the health care system has evolved over time due to technological innovation, policy changes, patient preferences, altering payment mechanisms, shifting demographics, and other factors. OBJECTIVE: The objective of this study was to examine trends over time in health care utilization and expenditures in the United States. RESEARCH DESIGN: This analysis employs descriptive statistics to examine 5 decades of health care utilization and expenditure data from the Agency for Healthcare Research and Quality (AHRQ) for 1977-2017. MEASURES: Measures include utilization and expenditures (not charges) for inpatient, emergency department, outpatient physician, outpatient nonphysician, office-based physician, dental, and out-of-pocket retail prescription drugs. RESULTS: We demonstrate that while health care expenditures have increased significantly overall and by type of care, utilization trends are less pronounced. The population of the United States grew 53% between 1977 and 2017, while annual total expenditures on health care increased by 208%. Amidst attention to out-of-pocket exposure for unexpected medical care bills, out-of-pocket payments for care have declined from 32% in 1977 to 12% in 2017 but increased in amount. CONCLUSIONS: This article provides the first extended snapshot of the dynamics of health care utilization and expenditures in the United States. Aspects of health care are much different today than in previous decades, yet the inpatient setting still dominates the expenditures.

Pursuing Value-Based Prices for Drugs: A Comprehensive Comparison of State Prescription Drug-Pricing Boards.

Policy Points In the absence of federal action on rising prescription drug costs, we reviewed the details of five states that have enacted prescription drug-pricing boards seeking to lower drug prices based on products' value. Within these states, six such boards are currently authorized; they have similarities but vary in terms of structure, authority, scope, and leverage. As of June 2021, only one of the boards in our sample has conducted pricing reviews; legislators in other states can learn from the successes and challenges of existing boards. Prescription drug-pricing boards represent a novel and promising way to curb state spending and pay for value in prescription drugs but face legal and political barriers in implementation. CONTEXT: Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with a variety of policies to contain spending and achieve value in prescription drugs. As part of this series of reforms, some state legislatures have recently authorized prescription drug-pricing boards to address the high prices of brand-name prescription drugs and assess the value of those drugs. METHODS: We identified state prescription drug-pricing boards in the United States, defined as any agency authorized by a state legislature to review specific drugs and pursue value-based drug prices. To describe the characteristics of the boards, we obtained public records of authorizing legislation, guidance documents, and board meeting minutes. We compared the boards' powers and responsibilities and analyzed completed pricing reviews. FINDINGS: Six state drug-pricing boards in five states met our definition; their design varied substantially. Two of the boards (New York Medicaid and Massachusetts) have authority over drug rebates paid by state Medicaid programs, one (New York Drug Accountability Board) has jurisdiction over state-regulated commercial insurance, and another three (Maine, Maryland, and New Hampshire) oversee non-Medicaid, state-funded insurance. Three boards are authorized to require manufacturers to confidentially submit information related to the pricing and clinical effectiveness of reviewed drugs to inform value determinations. Only one board (New York Medicaid) had completed pricing reviews as of June 3, 2021. CONCLUSIONS: Boards' structure, scope, and statutory leverages to compel manufacturers to negotiate lower net costs are key factors that influence whether and to what extent boards can achieve cost savings for states. Though legal constraints may limit the effective reach of prescription drug-pricing boards, these agencies can enable states to address rising prescription drug costs, in part by virtue of their very existence. To overcome practical limitations, states seeking to implement similar policies can build on the experiences and designs of current boards.

Why France Spends Less Than the United States on Drugs: A Comparative Study of Drug Pricing and Pricing Regulation.

Policy Points  Spending on prescription drugs is much higher per capita in the United States than in most other industrialized nations, including France.  Lower prescription drug spending in France is due to different approaches to managing drug prices, volume of prescribing, and global health budgets.  Linking a drug's price to value both at the launch of the drug and over its lifetime is key to controlling spending. Regulations on prescription volume and global spending complement the interventions on prices.  If the United States adopted the French approach to regulating drug pricing, Medicare could potentially save billions of dollars annually on prescription drug spending. CONTEXT: Prescription drug spending per capita in the United States is higher than in most other industrialized countries. Policymakers seeking to lower drug spending often suggest benchmarking prices against other countries, including France, which spends half as much as the United States per capita on prescription drugs. Because differences in drug prices may result from how markets are organized in each nation, we sought to directly compare drug prices and pricing regulations between the United States and France. METHODS: For the six brand-name drugs with the highest gross expenditures in Medicare Part D in 2017, we compared the price dynamics in France and the United States between 2010 and 2018 and analyzed associations between price changes in each country and key regulatory events. We also comprehensively reviewed US and French laws and regulations related to drug pricing. FINDINGS: Prices for the six drugs studied were higher in the United States than in France. In 2018, if Medicare had paid French prices for the brand-name drugs in our cohort, the agency would have saved $5.1 billion. We identified 12 factors that explain why the United States spends more than France on drugs, including variations in unit prices and the volume of prescriptions, driven by use of health technology assessment and value-based pricing in France. CONCLUSIONS: Key drivers of lower drug spending in France compared to the United States are that the French government regulates drug prices when products are launched and prohibits substantial price increases after launch. The regulation of prescription drugs in France is governed by rules that can inform discussions of US prescription drug policy and potential Medicare price negotiations.

Added Therapeutic Value of Medicinal Products for French and German Health Technology Assessment Organizations: A Systematic Comparison.

OBJECTIVES: Determining the price and reimbursement of a new medicine is a national competence within the Member States of the European Union that is carried out by health technology authorities and is based mainly on the added therapeutic value (ATV). The primary objective of this study was to compare the ATVs granted by the French (Haute Autorité de Santé, HAS) and the German (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWIG) authorities. The secondary objective was to analyze the reasons for the discrepancies observed. METHODS: Retrospective cohort of all ATVs assigned by HAS and IQWIG for the period 2011 to 2017. ATV assessments were classified as major, considerable, minor, no benefit, or not quantifiable. The concordance between the authorities was evaluated, and a qualitative analysis of highly discordant assessments was performed. RESULTS: One hundred and ninety-one drugs were evaluated by both agencies. The overall percentage of agreement was 50.3%. It was 73.1% for no benefit of ATVs, 37.5% for minor ATVs, 31.2% for considerable ATVs, and 5% for major ATVs. Highly conflicting assessments (n = 35) mainly concerned antineoplastic drugs (n = 14) and anti-infectives (n = 14). The main reasons for inconsistency concerned the following: a different appreciation of the subgroup analysis of efficacy data (n = 15), the appropriateness of comparators (n = 15), the surrogate endpoints (n = 10), methodological differences (n = 8), and the benefit/risk criteria that were used (n = 6). CONCLUSION: In the context of the common assessment of ATVs promoted by the European Commission, the harmonization between member states regarding the way evaluation criteria are assessed deserves to be addressed.

Assessing the Added Therapeutic Benefit of Ultra-Expensive Drugs.

OBJECTIVES: While the United States does not have a method for assessing the added therapeutic benefit of drugs, France, Canada, and Germany do. We examined the added therapeutic benefit of the most expensive drugs prescribed to Medicare Part D beneficiaries in the United States. METHODS: We identified ultra-expensive drugs with annual Medicare spending that exceeded $62 794 (United States GDP per capita in 2018) using Medicare Part D Prescription Drug Spending and Utilization Data. We used added therapeutic benefit ratings assessed by health technology assessment agencies in France, Canada, and Germany. RESULTS: We identified 122 ultra-expensive drugs in 2018. Sixty-five percent of these drugs (n = 79) were assessed by at least one of the countries. Based on these assessments, approximately 75% received a low added therapeutic benefit rating. CONCLUSIONS: Most ultra-expensive drugs prescribed in the United States and assessed by France, Canada, and Germany provide low added therapeutic benefit. Policy reforms in the United States could use added therapeutic benefit to inform coverage and pricing decisions for ultra-expensive drugs. Similar to Germany, one approach would be to allow the company to set a market price for a limited period of time before requiring a price reduction if the added therapeutic benefit is below a certain threshold. Another approach would be to identify when drug prices are substantially more expensive in the United States and conduct an added therapeutic benefit assessment and price review on these drugs.